CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 201 enrolled
Drug / intervention
Ultherapy treatment +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04795622
NCT04795622N/ACompleted
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Evaluation of the Effectiveness and Safety of the Ulthera® DeepSEE® System for Treating Skin Laxity in the Lower Face and Submentum

Merz North America, Inc.·interventional·Posted Mar 12, 2021·Updated Mar 23, 2023

In Brief

A clinical study evaluating Ultherapy treatment and Untreated-control / delayed-treatment for Improvement in Skin Laxity of the Lower Face and Submentum. Completed, enrolled 201 participants across 5 sites.

Detailed Summary

1. Demonstrate superiority of treatment with the Ulthera DeepSEE System compared to untreated control for the improvement of skin laxity of the lower face and submental area. 2. Demonstrate the safety of treatment with the Ulthera DeepSEE System for the improvement of skin laxity of the lower face and submental area.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImprovement in Skin Laxity of the Lower Face and Submentum
CountriesChina
CollaboratorsUlthera, Inc

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMar 12, 2021
Enrollment StartMar 16, 2021
Primary CompletionJan 18, 2022
Study CompletionMay 17, 2022
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 5.3 years ago

Interventions

Ultherapy treatmentdevice

Focused ultrasound energy delivered below the surface of the skin

Untreated-control / delayed-treatmentdevice

Untreated-control, followed by Ultherapy treatment (focused ultrasound energy delivered below the surface of the skin)